跳至主要内容
临床试验/CTRI/2025/04/084476
CTRI/2025/04/084476尚未招募Unknown

Clinical evaluation of nano-silver reinforced pit and fissure sealant and fluoride releasing pit and fissure sealant on permanent mandibular first molars : A Randomised Controlled Trial

Krishna Kajave1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年4月22日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Anatomic form, marginal adaptation, surface texture, marginal discoloration, retention, secondary caries.

研究概览

简要总结

Children who fulfill the inclusion criteria will be made to snit comfortably on the dental chair and the procedure to be done will be explained to the patient as well as the parent. Detailed case history will be recorded and written consent will be taken from the parents. The tooth undergoing pit and fissure placement will be cleaned, dried, etched and filled with the pit and fissure sealant. The sealant will be immediately light cured after its placement by 20 second exposure. Patient will be informed not to eat or consume any fluids for 30 minutes after sealant placement. Clinical evaluation of the sealed teeth will be done at 3- and 6- month interval using the modified USPHS rating criteria.

研究设计

研究类型
Observational

入排标准

年龄范围
7.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children visiting dental clinic for the first time between 7 to 10 years of age
  • Having fully erupted mandibular first molars with deep pits and fissures.

排除标准

  • Children and/or Parents who are unwilling to participate in the study.
  • Children allergic to aromatic and aliphatic dimethacrylates.
  • Children showing Frankl Behavior rating 1 and II (i.e. Definitely negative and Negative).
  • Children with special health care needs.

结局指标

主要结局

Anatomic form, marginal adaptation, surface texture, marginal discoloration, retention, secondary caries.

时间窗: 3 months and 6 months

次要结局

未报告次要终点

研究者

发起方
Krishna Kajave
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Krishna Kajave

KAHERs KLE VK Institute of Dental Sciences, Belagavi

研究点 (1)

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